Most-commonly requested product audits in compliance with FDA regulations

Published: 4-Nov-2003

A list of Premium Technology Providers, including several well-known and respected vendors, was released today by the Audit Repository Center. ARC is a unique clearing-house for standardised industry evaluations of commercial off-the-shelf (COTS) software and hardware products used by firms engaged in FDA-regulated industries.


A list of Premium Technology Providers, including several well-known and respected vendors, was released today by the Audit Repository Center. ARC is a unique clearing-house for standardised industry evaluations of commercial off-the-shelf (COTS) software and hardware products used by firms engaged in FDA-regulated industries.

According to Harvey Greenawalt, ARC President: 'The ARC organisation is pleased to announce that Agilent Technologies, Documentum, Inc., Fisher Rosemont Systems, MERANT, Inc., Mercury Interactive, and Sparta Systems, Inc. are 2003-04 PTPs. Audits of their software and systems in compliance with FDA regulations, including 21 CFR Part 11, continue to be the most popular requested by ARC subscribers.'

'Members of ARC,' explained Mr. Greenawalt, 'include Bristol-Meyers Squibb Company, Eli Lilly & Co., Novartis Pharmaceuticals Corporation, Pfizer, Schering-Plough and dozens of other leading pharmaceutical companies.

Pharmaceutical industry members now, at significantly reduced cost, can obtain this data for the computer services and products they use. The PDA Process repository administrated by ARC for PDA provides the means to share data collected in accordance with the industry standard process defined in PDA Technical Report #32 between and among participating companies.

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